Completed
Pilairo Lab Market Research
What is being tested
CPAP mask ( Pilairo)
+ Other CPAP mask
DeviceProcedure
Who is being recruted
Apnea+6
+ Nervous System Diseases
+ Respiration Disorders
Over 18 Years
+5 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: December 2012
Summary
Principal SponsorFisher and Paykel Healthcare
Last updated: March 9, 2018
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2012
Actual date on which the first participant was enrolled.The purpose of the study is to observe the Pilairo mask in a lab setting, compared to other commercially available masks for continuous positive airwary pressure (CPAP) therapy.
Principal SponsorFisher and Paykel Healthcare
Last updated: March 9, 2018
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
ApneaNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSleep Apnea SyndromesSleep Wake DisordersSleep Disorders, IntrinsicDyssomniasSleep Apnea, Obstructive
Criteria
2 inclusion criteria required to participate
Apnea Hypopnea Indea > 15 from diagnostic study
Minimum 18 years of age
3 exclusion criteria prevent from participating
Anatomical or physiological conditions making CPAP therapy inappropriate
History of intolerance to CPAP
Inability ot give informed consent
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalPilairo nasal pillows mask during CPAP titration
Group II
Active ComparatorOther CPAP mask during CPAP titration
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center